U.S. government grants wider indication for anti-bleeding product

Humate-P, a product made from human plasma, is manufactured by CSL Behring GmbH, Marburg, Germany. The company is a subsidiary of CSL Ltd. of Australia.

Von Willebrand disease is the most common inherited bleeding disorder, affecting about 1 percent of the U.S. population, the FDA said.

The FDA said Humate-P is approved for use in patients in whom the medication desmopressin may not work.

Humate-P was originally approved for use in adult patients to treat and prevent bleeding from hemophilia, the agency said.

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